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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252765

510(k) cleared

ProSomnus RPMO2 OSA Device (RPMO2 OSA)

Prosomnus Sleep Technologies · Apr 6, 2026 · K252765

FDA cleared the ProSomnus RPMO2 OSA Device (RPMO2 OSA) from Prosomnus Sleep Technologies on Apr 6, 2026 under K252765, a traditional 510(k). The device falls under product code PLC, Sleep Appliances With Patient Monitoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 29, 2025. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Prosomnus Sleep Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252765?

K252765 is the FDA 510(k) for ProSomnus RPMO2 OSA Device (RPMO2 OSA), submitted by Prosomnus Sleep Technologies. FDA's decision date was Apr 6, 2026, under product code PLC (Sleep Appliances With Patient Monitoring).

Who makes the ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

Prosomnus Sleep Technologies, based in Pleasanton, CA, is the applicant of record for K252765.

How long did the K252765 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Apr 6, 2026, 220 days later.

← All decisions in April 2026